Radiohead are auctioning a guitar, Peter Kay and Badly Drawn Boy are performing live shows and donating the proceedings to the Billie Butterfly Fund.

It’s a moving story, Billie is a four year old girl with an inoperable brain stem tumor. Chemotherapy only offers some respite but the family have found another way…

Or so they believe.

For just £200,000 Billie will be allowed to enrol on a ‘clinical trial’ of antineoplastons at The Burzysnki Clinic. This may cure Billie for good, they believe. In the observer

(“The worst year of my life: cancer has my family in its grip | From the Observer | The Observer,” Bainbridge, 2011) Luke Bainbridge (Billie’s uncle) writes “Is it impossible for her to survive? No, as it turns out. Sam and Terri very quickly found out about a pioneering treatment at the Burzynski Clinic in Texas for children with DIPG. The estimated cost is £200,000.”

However, not all is as it seems.

So why does this matter?

For a start, if Burzynski can cure cancer then he deserves a noble prize. He is also professionally and ethically obliged to publish his results, demonstrating that he can cure, for the greater good of humanity and society.

If Burzysnki cannot cure cancer then he is ethically obliged to release the results of his clinical trials, so that we can make a firm conclusion that antineoplastons are not effective against cancer. This would enable researchers and patients to focus their energy, time and money elsewhere. As you’ll see Burzynski’s treatment is not cheap, if it’s also useless then Burzynski is doing nothing more than praying on the desperate, ill and vulnerable in society and selling them false hope in return. If Burzynski’s treatment doesn’t work then there is no need for Burzynski to continue running ‘clinical trials’ to find out.

Before we delve into Burzynski’s research lets first look at the other public campaigns to raise money to get people this treatment and how they turned out.

Burzynski In The Press: Fundraising and Outcomes

There have been several similar campaigns to raise money to get someone into Burzynski’s clinic, a whole bunch have been reported on here, (“Stanislaw Burzynski’s public record « Skeptical Humanities,” RJB, 2011) . Here are some quotes I found interesting from that article:-

“Parents of Zoe Lehane Levarde were trying to raise 1 million for treatment at the Burzynski Clinic (1 million to get into a drug trial?). Zoe is now dead.”

“Luna Petagine needed to raise $20,000 to just find out if she was eligible for the unproved treatment.”

“a five-year old girl, Raphaelle Lanterne, died after her parents went against medical advice and saw Burzynski.”

“Mirjam Binnendyk, 24, went to Burzynski’s clinic, reports the Montreal Gazette in 2001, and she was happy with the treatment at the time, though the $200,000 price tag was an out-of-pocket expense. She appears to have died in 2008”

“From the Globe and Mail, 9 March 2o00:

“Jean and Tom Walsh also found Dr. Burzynski on the Internet. Their 26-year-old daughter, Andrea, had also been diagnosed with a fast-growing brain tumour. They borrowed $16,000 to start her treatment, then borrowed more. Andrea suffered severe side-effects, including high fevers, disorientation and constant thirst. When Jean complained, the nurses told her these were signs the tumour was breaking up. A few weeks later, she was told that Andrea would soon be back to work. “I can’t tell you how happy we were,” Jean recalled. Her daughter died two days later, on the plane on her way home. That was 2½ years ago. Jean and Tom are still paying off their debts.”

“Rosmari Brezak, whose treatment was projected to cost $300,000, after five weeks in treatment at the clinic, had a massive seizure and lapsed into a coma. She died on March 9.”

The article details several other cases and states:-

“Of the records I search, I found one girl who seems to have beaten cancer into a 3rd remission. Almost everyone else I saw who had been touched by this guy is dead.”

It is clear from these reports that Burzynski charges an unreasonably high price in order to enlist people into clinical trials. The most mind boggling thing is that people usually volunteer to take part in clinical trials, volunteers are often paid to take part, or do so in order to help researchers gain more insight into their condition. This research is then published, shared and reviewed so that researchers and doctors around the world can use that knowledge. That isn’t how Burzynski does business. In fact, there is a petition to get Burzynski to release the results of his ‘clinical trials’ here.

“Dr. Burzynski first gained fame for his cancer therapy back in 1988, when Sally Jesse Raphael featured four “miracle” patients of Burzynski’s, who, according to her, had had incurable cancer and failed conventional therapies but were rendered cancer-free, thanks to Dr. Burzynski. Unfortunately, four years later in 1992, Inside Edition followed up these four patients and found that two of the four had died and a third had recurred, while the fourth had had bladder cancer with a good prognosis. In that report, the widow of one of Raphael’s guests reported that her husband and five others had sought treatment from Burzynski and that all had died.” (“Science-Based Medicine » Stanislaw Burzynski: Bad medicine, a bad movie, and bad P.R.,” Gorski, 2011)

It would appear that once you’ve been convinced of the Burzynski treatment you will support it, campaign for it and do absolutely anything to get the money to go. Then it wont work and you will die…but onces dead you cannot complain. You can’t campaign and create awareness, you can’t file a lawsuit for fraud, and so it continues…

The first red flag is that he charges. It appears that this is a loophole in the american ethics system. Burzynski’s treatment is not FDA approved, however he is allowed to treat people as long as he calls it a clinical trial. Even if these clinical trials never ever release any of their data so that nobody can have any idea whether it really works or not. The ethical loophole is discussed here (“BishopBlog: The weird world of US ethics regulation,”).

The second red flag is that he charges so much, especially for deposits and unreasonably high ‘case management’ and consultation fees. You can find more about these costs here(“Big business in Texas | Zeno’s Blog,” Henness, 2011).

The third red flag is that after raising the funds with these campaigns, almost every single time Burzynski gets the money and then the patient ends up dying, of cancer or due to a side effect of the treatment.

But there is more still, one family are very unhappy with the way Burzysnki works and have set up a website called burzynskiscam.com and they state:-

“Along with the long list of other meds that were supposed to work in conjunction with each other, the Burzynski Clinic gave my husband standard chemotherapy medications. We were never told that two of the medications were conventional chemo medications. We discovered from our local pharmacy that one medication the Burzynski Clinic had charged us over $2300.00 for could have been purchased from the pharmacy for around $170.00.”

(“BurzynskiScam.com | Home,” The Merritts)

Apparently a lot of the money doesn’t even go on Burzynski’s own treatment, much of it comes from selling conventional chemotherapy at ridiculous prices for a massive profit without being honest about it. This is clearly unethical and unprofessional. I’m not sure how Burzynski justifies charging these extortionate prices. This is a guy that claims Big Pharma have a secret conspiracy to make money from their cancer treatments, which he also calls ‘harmful’ and yet according this, not only does he sell them himself, he sells them at an astonishing 1253% increase on the ‘Big Pharma’ price!

The Merritts also go on to state Burzynski had claimed he had evidence of patients with pancreatic cancer surviving up to five years with his treatment, when asked for a list they managed to contact three people with pancreatic/liver treatment that had been treat by Burzynski. It turned out Burzynski didn’t have evidence for people surviving 5 years, he didn’t even have evidence of a single person with that type of cancer surviving for one year.

Before examining Burzynski’s ‘clinical trials’ and published research (what there is of it), lets look a bit more closely into Burzynski, the person.

Burzynski: The History – Is Burzynski A Fraud?

Here are some useful quotes about the background of Burzynski.

“Burzynski attended the Medical Academy in Lubin, Poland, where he received an M.D. degree in 1967 and an D.Msc. degree in 1968. He did not undergo specialty training in cancer or complete any other residency program. His bibliography does not mention clinical cancer research, urine, or antineoplastons during this period….

He got a license to practice medicine in 1973 and, with others, received a three-year grant to study the effect of urinary peptides on the growth of cancer cells in tissue culture. The grant was not renewed….

In 1976, with no preclinical or clinical cancer research experience, Burzynski announced a theory for the cure of cancer based on his assumption that spontaneous regression occurs because natural anticancer peptides, which he named antineoplastons, “normalize” cancer cells. Since urine contains lots of peptides, he concluded that there he would find antineoplastons. Less than one year later and based only on these assumptions, Burzynski used an extract from human urine (“antineoplaston A”) to treat 21 cancer patients at a clinic he opened. His shingle read, “Stanislaw R. Burzynski, M.D., Ph.D.”

Burzynski’s claim to a Ph.D. is questionable. When I investigated, I found:

An official from the Ministry of Health in Warsaw informed me that when Burzynski was in school, medical schools did not give a Ph.D. [1].

Faculty members from at the Medical Academy at Lubin informed me that Burzynski received his D.Msc. in 1968 after completing a one-year laboratory project and passing an exam [2] and that he had done no independent research while in medical school [3].

In 1973, when Burzinski applied for a federal grant to study “antineoplaston peptides from urine,” he identified himself as “Stanislaw Burzynski, M.D, D.Msc.” [4]”

(“stanislaw burzynski and ‘antineoplastons’,” quackwatch)⁠

“You will notice that Dr Burzynski gained a PhD in a single year while being employed full-time at the Medical University of Lublin in Poland. This university does not have a doctoral program, so I wondered where Dr Burzynski did his studying, thesis research and writing, and his dissertation…

….So, my question is “Where did Dr Burzynski get his PhD from?”. Failing a verifiable answer I will just have to assume that he is lying about his qualifications. Or, put another way, being just as truthful as he is in his claims of having cured people of cancer.”

Peter Bowditch searches University Microfilms (ProQuest), who have been documenting dissertations for 130 years and fails to find the PhD for our Dr. Stanislaw R. Burzynski. It would seem the Burzynski claims to have a PhD but does not, or at least not from a recognised certified institution.

“In 1997, the government failed in two attempts to convict Burzynski. One trial ended in a hung jury. Another produced a not guilty verdict.” The Cancer Letter, Vol. 24, No. 36, Sept. 25, 1998.

Burzynski has had a long run in with the law, there are some details of this described in The Cancer Letter (1998, taken from quackwatch(“The Antineoplastin Anomaly,”). This article goes into a lot of depth about everything that was known about Burzynski in 1998, as well as the political background at the time which allowed Burzynski to skip phase one testing and go straight into phase 2 and yet continually avoiding the all important phase 3 randomised control trials.

His Wiki page and this document from the United States Court of Appeals, Fifth Circuit, also state that Burzynski was found guilty of fraud in 1994 for claiming reimbursement from a health insurer for an illegally administered cancer treatment.

These examples suggest that in the past Burzynski has been sued for fraud and sheds grave doubt on the honesty and professionalism of this practitioner.

“But hey man, Have you seen the film!?”

First – A film is not evidence for success of a treatment. I could grab a bunch of my mates and get them to pretend that drinking the magical elixir I spat into a glass form them cured them all of every illness in the world ever and made them all millionaires, but that wouldn’t make my spit a wonder drug, would it?

Second – Anecdotes are also not evidence, to find out if a drug works isn’t actually that difficult, you just compare the current drug with placebo, normal treatment and your new drug by randomly allocating people that want treatment for those illnesses into those groups. This means that you can’t choose people who appear to be doing better and put them in your preferred group, it also demonstrates that all things being equal (you have to have entry criteria which is fairly strict to ensure all things are equal and fair) that the any differences in the groups is most likely down to the differences in the way they were treat (i.e. placebo, antineoplastons, normal chemotherapy). The problem with an anecdote – a personal story – is that someone may believe they have been cured of cancer, and then later die of cancer. Which is what has happened to almost 100% of people that have been in the media claiming that Burzynski has cured them of cancer.

They both conclude very similar things about this movie and the three cases which are presented to ‘prove’ Burzynski’s treatment works.

As Gorski is a cancer surgeon and researcher I’m going to quote him heavily and expect you to read his full blog post. Here is some of what David Gorski says about case one:-

“It’s highly unusual for any chemotherapy (and, make no mistake, antineoplastons are chemotherapy) to shrink a tumor that fast.

This brings up an intriguing possibility, mainly that the bulk of the tumor was removed by the biopsy process. I’m not a neurosurgeon, but I’ve seen the same sort of thing happen occasionally in small breast cancers that undergo a core needle biopsy, especially using a large biopsy needle; so it’s not inconceivable to me that the same thing might happen in brain tumors. Whether such a thing is possible or not, it should also be noted that anaplastic astrocytomas can have a highly variable prognosis and growth rate, which means that Fenton’s prognosis might not have been as bad as portrayed in the movie.

So what happened here? It’s clear that this case was presented first because the film’s producers thought this was their strongest case, mainly because the patient hadn’t undergone any therapy before being treated with antineoplastons. So one of three things happened:

1. The biopsy removed the cancer, and what was left behind was an inflammatory reaction.

2. The biopsy removed much of the cancer, and antineoplastons worked on the rest

Fenton is an outlier whose tumor regressed on its own

Again, if Burzynski had real evidence that his therapy worked (i.e., clinical trial evidence), then he wouldn’t be resorting to anecdotes like this one, which doesn’t show conclusively that it was the antineoplastons that eliminated the tumor.”

Case two:-

“it takes the tumor over a year to disappear, and it doesn’t even start to shrink consistently until nearly nine months after antineoplaston treatment started. This sort of behavior is strongly suggestive to me that the treatment probably had little to do with the disappearance of the mass, as drugs that are active against a tumor generally result in measurable shrinkage a lot faster than that and the tumor actually increased in size for a while during antineoplaston therapy. Moreover, the changes in tumor size don’t appear to correlate very well to the changes in dosage. After all, if the tumor shrank significantly on the MRI of September 21 and Burzynski attributes that to doubling the dose of antineoplastons, then how does he explain the tumor size increasing significantly again on the November 11 scan? In any case, the behavior of this tumor makes me wonder about the diagnosis, which makes me wonder why the pathology report isn’t included, as it was for the other two testimonials. Could it be that there was no biopsy of this tumor? If that’s the case, then there are many reasons to doubt that this was ever a brainstem glioma in the first place, first, because its behavior was not consistent with one and, second, because brainstem tumors are heterogeneous and even highly suspicious lesions on MRI can be benign 13% of the time.”

Case 3:-

“More puzzling is, again, the behavior of the multiple liver and lung masses noted in the supplemental data. First, the raw data presented don’t match the parents’ description in that there are no liver masses noted until 2/22/2006, which is nearly six months after the initial surgery. It’s also inconsistent with the narration of the movie:

Upon the removal of Kelsey’s left kidney and left adrenal gland, her diagnosis was confirmed at the University of Texas Medical Branch, and again at M.D. Anderson cancer center. Where, a month later, M.D. Anderson also confirmed that Kelsey’s cancer had spread to her lungs. After desperately researching Kelsey’s situation, her family decided to decline all chemotherapy treatments offered my M.D. Anderson, and instead, enroll Kelsey into one of Dr. Burzynski’s clinical trials. By this time, Kelsey’s cancer had also spread into her liver.

Again, Kelsy’s surgery was in September 2005; no evidence of liver metastases appears to have been noted until February 2006. When did she start the antineoplaston therapy? Was it shortly after surgery? If that’s the case, then her liver lesions developed and her lung lesions grew while she was on the antineoplaston therapy. Or did she not start antineoplastons until the appearance of liver lesions in February? If that’s the case, then why did her doctors leave her untreated for five months while her lung masses increased in size? No, what seems most likely is that antineoplaston treatment began soon after surgery, Kelsy’s tumors grew for several months after that, and new liver lesions appeared while she was on therapy. Of course, it’s not even clear if these lesions were metastases because there’s no evidence that Burzynski or Kelsy’s other doctors ever biopsied any of them. Again, there are no pathology reports of core needle biopsies of the suspected metastases.

In brief, Merola’s pledge that the the opening 30 minutes of the movie would “thoroughly establish” that Burzynski has discovered the genetic mechanism that can cure most cancers was not kept. These three testimonials do not constitute convincing evidence that antineoplastons can cure cancer. Given that they are almost certainly the absolute best cases that Burzynski could come up with, I’m once again forced to wonder what the denominator was. Meanwhile, interspersed throughout these testimonials are comparisons of Burzynski’s results to results of standard therapy that are deceptive in the extreme, given that small, unrandomized groups subject to selection bias are not comparable to larger clinical trials of standard-of-care treatments.”

The movie is trash. Little more than an advert for Burzysnki’s treatment. Pseudo-Scientific, emotionally manipulating propaganda. The cases presented in the movie do not suggest Burzynski has a useful therapy for the treatment of any type of cancer.

“The Burzynski treatment is piss. Literally. A mixture of substances extracted from the patient’s own urine is dubbed with the preoposterous pseudoscientific name “antineoplastons”. There are no such things as “neoplastons”,The main component seems to be a simple organic chemical, phenylacetic acid (PA). It is produced in normal metabolism but the liver copes with it by converting it to phenylacetyl glutamine (PAG), which is excreted in the urine.” (Colquhoun, 2011)⁠

“In reality, AS-2.1 is phenylacetic acid (PA), a potentially toxic substance produced during normal metabolism. PA is detoxified in the liver to phenylacetyl glutamine (PAG), which is excreted in the urine. When urine is heated after adding acid, the PAG loses water and becomes 3-N-phenylacetylamino piperidine 2,6-dione (PAPD), which is insoluble. Normally there is no PAPD in human urine.

What Burzynski calls “A-10″ is really PAPD treated with alkali to make it soluble. But doing this doesnot create a soluble form of A-10. It simply reinserts water into the molecule and regenerates the PAG (Burzynski’s AS-2.5). Further treatment of this with alkali breaks it down into a mixture of PA and PAG. Thus Burzynski’s “AS-2.1″ is nothing but a mixture of the naturally occurring substances PA and PAG.

Burzyski claims that A-10 acts by fitting into indentations in DNA. But PAG is too big a molecule to do this, and Burzynski himself has reported that PAG is ineffective against cancer [5,6].

PA may not be safe. In 1919, it was shown that PA can be toxic when ingested by normal individuals. It can also reach toxic levels in patients with phenylketonuria (PKU); and in a pregnant woman, it can cause the child in utero to suffer brain damage.

Burzynski has never demonstrated that A-2.1 (PA) or “soluble A-10″ (PA and PAG) are effective against cancer or that tumor cells from patients treated with these antineoplastons have been “normalized.” Tests of antineoplastons at the National Cancer Institute have never been positive. The drug company Sigma-Tau Pharmaceuticals could not duplicate Burzynski’s claims for AS-2.1 and A-10. The Japanese National Cancer Institute has reported that antineoplastons did not work in their studies. No Burzynski coauthors have endorsed his use of antineoplastons in cancer patients.”(Green, 1997)⁠

Burzynski: The Evidence – Antineoplastons, Do They Do Anything For Cancer?

The thing is Burzynski has been running ‘clinical trials’ on this treatment for 30+ years, he claims to have treated eight thousand patients. On his website in 2000 he listed 72 clinical trials were being conducted and clinic gov lists 61 registered trials. In this time one has been completed but the results have not been published. What is worse is that 35 of them are listed as ‘status unknown’ (how on earth can you not know the status of your own clinical trial?), 7 were withdrawn and two were terminated. It seems to me highly unethical to terminate or withdraw a clinical trial which has been paid for by the patient, with a very large sum, and not put that data to good use somewhere, for any reason.

The most recent (S. R. Burzynski, T. J. Janicki, R. A. Weaver, & B. Burzynski, 2006) is a methodological nightmare. It’s unclear how many patients were originally signed up to the study, however the research states that 18 of the participants were evaluable. Eighteen is too low a number to establish anything either way, Burzynski either knows this and continues to choose studying small populations to deliberately make it difficult to judge the efficacy of his treatment, or he does not know this and is in that case an absolutely useless researcher. Of course, Burzynski, as we know, also doesn’t compare the effects of his treatment group with any other kind of control group. Not even a placebo group, which is odd because to decide wether or not Burzynski’s treatment is actually worthwhile at all it should be compared to the currently best available treatment for that type of cancer. Not just a placebo. Basically, even his last piece of research, as far as making clinical treatment decisions goes, is of absolutely no value or worth. Any judgement based on such preliminary data is premature and invalid.

What’s worst is that out of his 18, probably best cases, Burzynski reports that only 39% of these eighteen survived two years, with 78% of participants dead within five years. S. R. Burzynski et al. (2006) describes a ‘complete response’ as disappearance of the tumor for four weeks (this is far from a lifelong clearance of cancer), he also defines ‘partial response’ as a 50% decrease in the tumor for 4 weeks. ‘Stable illness’ is described by Burzynski any change in the size of tumor which is less than 50%. Which obviously means if the tumors were slow growing they could easily have been portrayed as ‘stable’ by Burzynski. That being said he still only reports two cases of complete response and two cases of partial response, with seven cases classified as ‘progressive disease’, a 50% increase in cancer size and another seven classified as stable, that is up until 78% of all the patients had died, of course.

This is hardly an impressive study.

Also: -

Why has Burzynski published nothing in five years, yet continues making millions charging large sums for patients to take part in his ‘clinical trials’?

The next study listed has the same methodological problems and fairly terrible outcomes. This time the experiment was conducted on 13 children, this time 54% were dead within five years, this seems odd since the abstract opens “Primitive neuroectodermal tumors (PNETs) are usually successfully treated with craniospinal radiation and chemotherapy”(S. R. Burzynski et al., 2005) and Burzynski et al, 2005 themselves admit “The serious side effects included single occurrences of fever, granulocytopenia, and anemia. The study is ongoing and accruing additional patients. The percentage of patients’ response is lower than for standard treatment”.

An interesting point to note is that Burzynski claims his antineoplastons are not toxic, this study proves that they are toxic.

In (S. R. Burzynski, R. A. Weaver, et al., 2004) Burzynski claims that his results are favourable compared to standard chemotherapy. This is incorrect, since Burzynski’s trial does not compare his treatment with standard chemotherapy.

S. R. Burzynski, Lewy, et al. (2004) reports on a single patient, out of thousands of patients this is apparently Burzynski’s one success story. It is probably just a spontaneous remission and the long term survival of the patient is likely to have nothing to do with the Burzynski treatment. The reason that I’m coming to this conclusion is that the studies looked at so far suggest that the treatment is either useless or harmful.

S. R. Burzynski et al. (2003) report a study, this time of ten ‘evaluable patients’. It is unclear in this study how many patients were recruited and what criteria excluded them from being ‘evaluable’. This time the survival of his treatment for 2 years was 33.3%. That means 67% of the patients were dead within two years, one was alive for more than five years since starting the treatment, another for more than four years. Burzynski also seems to say two were alive for five years since initial diagnosis, in order to try and take credit for this by lenghtening the overall survival time, rather than talking about how long they survived after starting his treatment. They also report on the toxicity of his antineoplaston treatment which included three cases of skin allergy, two of anaemia, fever and hypernatraemia and cases of agranulocytosis, hypoglycaemia, numbness, tiredness, myalgia and vomiting (S. R. Burzynski et al., 2003).

Buckner et al. (1999)⁠ conducted a trial on antineoplaston therapy on nine patients, they report that no patient treated with antineoplaston demonstrated any tumor regression. This means that the treatment, in this study, simply and clearly did not work. They also report that severe neurotoxicity can occur. Vickers (2004)⁠ reports on this, stating further, that six patients demonstrated tumor progression, that the mean time to treatment failure was 29 days and that all nine patients died before the study was complete.

Gorski states:-

“Out of curiosity, I did a quick search of ClinicalTrials.gov for clinical trials by Burzynski or containing the word “antineoplaston.” I found 61 clinical trials, of which only ten are listed as still recruiting subjects, with one listed as not yet open. Over thirty are of unknown status, and only one is completed. This is an an apparently unrandomized, open-label phase II trial trial testing antineoplastons A10 and AS2-1 therapy in melanoma. In fact, none of the currently open antineoplaston trials are phase III trials, which are the type of trial that can potentially give a definitive answer about a therapy, because phase III trials are randomized, controlled trials. The only phase III trial listed is A Randomized Phase 3 Study of Combination Antineoplaston Therapy [Antineoplastons A10 (Atengenal) and AS2-1 (Astugenal)] vs. Temozolomide in Subjects With Recurrent and / or Progressive Optic Pathway Glioma After Carboplatin or Cisplatin Therapy. It’s a small trial (only 70 subjects) and appears at first glance to be underpowered to detect anything but very large differences in outcomes. I realize that many of Burzynski’s trials date back before the database used in ClinicalTrials.gov was active, but come on! Sixty-one clinical trials since the 1990s, with the end result being only one phase III trial, and that phase III trial hasn’t even started yet? And most of the phase II trials of “unknown” status and only one of them listed as “completed” (with that one apparently not having been published)? That’s a failure in my book. No drug company or researcher would keep doing trials of a drug (and, yes, antineoplastons are drugs when used this way) with such an abysmal track record. A drug company would give it up as unpromising, and a university researcher would soon find he could no longer secure funding for more trials.

All of this leads to the question of how Burzynski could have run so many clinical trials and have so little to show for it? There are at least 61 clinical trials registered at ClinicalTrials.gov; yet finding the results of any of them is very difficult. Among the open trials, most of them are several years old, some 16 years or more, but have not accrued their targets, even though they are all phase II trials with accrual targets of fewer than 50 subjects each. When a trial takes that long to accrue, the vast majority of the time its results will be meaningless.” (“Science-Based Medicine » Stanislaw Burzynski: Bad medicine, a bad movie, and bad P.R.,” Gorski, 2011)

“The Burzynski’s clinic’s pitch uses the same time honored formulae of all snake oil dealers. More importantly Burzynski’s publications are all in weak journals, in addition the science is week. To follow is my critique of one of his articles on brain stem tumors entitled “Targeted therapy with Antineoplastons A10 and AS2-1 of High Grade, Recurrent and Progressive Brainstem Glioma”.

1. The paper is published in the journal Integrative Cancer Therapies, the web site of which describes it as a “peer-reviewed quarterly journal focused on the scientific understanding of alternative medicine and traditional medicine therapies, and their responsible integration with conventional health care.”. The editorial board of this journal includes Ralph Moss, PhD who has written about Burzynski in his book The Cancer Industry.

2. In the paper both adults and children are included in the same cohort. However it is well documented that the biology of brain stem tumors is very different between adults and children. As emphasized in a paper published last month in the respected journal Neuro-Oncology entitled “treatment of High Grade glioma in children and adolescents”, by Macdonald et al, 13 (10): 1049-1058, it is stated that “Efforts to develop effective therapies for HGGs in children may not be able to rely on progress made with adult high grade gliomas (HGGS). While the histology of HGGs between adults and children appear identical , the biology of the tumors may vary significantly.”

3. Burzynski also includes different types of brain stem tumors in his paper, although the majority are DIPG, exophytic, cervico-medullary and multifocal tumors are also included. The paper “A Clinico-Pathological Reappraisal of Brain Stem Tumor Classification” by Fisher et al from Johns Hopkins (Cancer, Oct, 2000, Vol 89 (7) ) elegantly explains the difference in prognosis between the various brain stem tumors.

4. If one teases out the children under 10 from Burzynski’s paper the overall survival from diagnosis is 11 months. No different from that obtained with radiation therapy.This is in opposition to the overall 5 year survival of 22% that is stated in the paper.

5. The point is that parents of unfortunate children with diffuse pontine glioma could look at this paper and come away with the conclusion that their child could have a 22% chance of survival with antineoplaston treatment.

6. This is intellectual fraud.

In conclusion, I remain unconvinced about the validity of Burzynski’s work.

The results of this study demonstrate 92% of the patients were dead within five years. It’s likely that this remaining 8% were simply lucky enough to survive for longer, this survival could also be due to other treatments given before, during or after Burzynski’s (remember, we have been told that he sells traditional chemotherapy drugs, with a large mark up, without telling patients that they are in fact conventional chemotherapy drugs).

Cuerden concludes:-

“The conference abstract also reports on subjective results based on looking at patient MRIs, and there is nothing in the paper to suggest that these assessments were properly blinded (the person doing the analysis might have known that Burzynski was treating the patient). The subjective results are claimed to show:

Since we know only 8% will survive 5 years, that 23% “complete response” can’t represent an actual complete cure. This indicates that the MRI scans probably aren’t a particularly good way of predicting if patients will survive, although we might be able to speculate that it shows something. Or we could if the study had employed proper robust controls and linked the tumour response to survival rate, but, since there’s no controls, and the survival rate isn’t compared with the tumour response, all we can say is that the tumours behaved in varying ways during the period of time that the trials happened, for unknown reasons. We’ll see if some of Burzynski’s other articles do a better job at explaining this in future posts.

Finally, the conference abstract claims:

“The preliminary results of our small study of adults with recurrent mixed gliomas revealed ANP to be very effective in resolving or stabilizing disease in more than 50% of treated patients”.

No, it doesn’t. 92% of them were dead in 5 years. This is a classic abuse of trials – selecting subjective results that say what you want to find, and ignoring objective results that show the opposite”(“The 21st Floor » Blog Archive » Analysing Burzynski,” Cuerden, 2011)

“At the moment, there is very little solid scientific evidence to show that antineoplastons are effective at treating cancer, and virtually all the research in this area has been carried out by Burzynski and his team – a red flag to the scientific world (as we’ve discussed before).

…

The fact that no other labs have managed to replicate Burzynski’s apparent success with antineoplastons or are interested in developing the treatment raises questions.

As a case in point, based on his claims about antineoplastons, the US government-funded National Cancer Institute (NCI) spent nearly a million dollars on an early-phase clinical trial of Burzynski’s treatment in the early 1990s. But the early results were not promising and the trial ended in disarray – a saga documented in this fascinating social science paper.

….it is perplexing that since then thousands of patients have allegedly been treated with antineoplastons, yet there is not enough data to make a solid case for their effectiveness. And – more importantly – based on the evidence presented by Burzynski, the vast majority of the scientific and medical community remains unconvinced.

As well as the doubts around the effectiveness of the treatment, the whole manner in which the clinic is offering treatment is unusual.

Antineoplaston therapy is not licensed as a cancer treatment by the US Food and Drug Administration (FDA), so the Burzynski Clinic is offering the treatment only as part of a clinical trial. However, patients are being asked to pay many tens of thousands of dollars for the privilege of being on the trial – a highly unusual situation in clinical research, and certainly not the norm for UK trials.

Furthermore, the scientific community expects the results of clinical trials to be published in the medical literature. As far as we can tell, Burzynski’s team have not published any results since 2006, which raises questions about exactly what kind of clinical trials they are running, and when we might expect to see the detailed analysis of their results.”(“Hope or false hope? : Cancer Research UK – Cancer Research UK – Science Update blog,”)

Although Burzynski likes to claim he runs ‘FDA Approved trials’ the FDA in 2009 actually issued a warning to Burzynski (Leslie K. Ball, 2009)which you can read here) because his IRB (ethics committee) fails to protect human subjects.

“The primary purpose of the IRB is to protect clinical trial patients from ethical abuses. To summarise the letter, the main violations were:

Failing to report to the FDA that BRI had dosed human subjects without IRB approval.

Allowing a study to proceed, despite asking for further pre-clinical toxicology data.

Allowing a study to proceed without an investigator’s brochure having been submitted (the investigator’s brochure is the detailed summary of all data to date, and is mandatory for all investigational drugs).

Approving the use of a medical device without assessment of risk.

Failing to ensure that BRI obtained informed consent from patients or guardians.

Conflict of interest between BRI and the IRB – the IRB chairman was also an investigator.

Failing to carry out regular review of ongoing studies.

Multiple failures to maintain files and documents, including minutes of meetings.

Co-opting external people onto the IRB, against FDA rules.

Note that the FDA has not issued a close-out letter, hence the IRB has so far failed to remedy these breaches”(“Clinical Trials for Sale « Majikthyse,” )⁠

“- failure to practice medicine in an acceptable professional manner consistent with public health and welfare;

- failure to meet the standard of care;

- negligence in performing medical services;

- failure to use professional diligence;

- failure to safeguard against potential complications;

- failure to disclose reasonably foreseeable side effects of a procedure or treatment;

- failure to disclose reasonable alternative treatments to a proposed procedure or treatment;

- failure to obtain informed consent from the patient or other person authorized by law to consent to treatment on the patient’s behalf before performing tests, treatments, or procedures; and

-prescription or administration of a drug in a manner that is not in compliance with Chapter 200 of this title (relating to Standards for Physicians Practicing Complementary and Alternative Medicine) or, that is either not approved by the Food and Drug Administration (FDA) for use in human beings or does not meet the standards for off-label use, unless an exemption has otherwise been obtained from the FDA.

- unprofessional or dishonorable conduct that is likely to deceive or defraud the public or injure the public;

- providing medically unnecessary services to a patient or submitting a billing statement to a patient or a third party payer that the licensee knew or should have known was improper. “Improper” means the billing statement is false, fraudulent, misrepresents services provided, or otherwise does not meet professional standards.”

This article also describes how Burzynski could fall foul of UK law and explains how The Observer failed to follow the Medical Health Regulatory Agency (MHRA) guidance on health news reporting.

You can e-mail the editor of The Observer and tell them you are upset by the biased reporting of their article. That it was irresponsible of them to portray The Burzynski Clinic in such an uncritical light as this may lead to further individuals succumbing to Buryznski propaganda, which would at best mean a combination of unproven and traditional treatments at a very high price and at worst a dangerous combination of treatments, illegal prescriptions and extortionate prices, a bit of fraud, plus a lot of false hope.

Pressure should be put on the Burzysnki Clinic to prove the efficacy of it’s treatment using a phase 3 RCT or to shut down and stop running these faux ‘clinical trials’.

Pressure should be put on the FDA to ensure future Burzynski clinical trials can be ethically justified. It is unclear how 61 clinical trials all on the same treatment, with the same poor designs, to answer the same research questions was ethically justifiable in the first place. No further trials of this type are necessary. The results of these trials need to be analysed, scrutinised and peer-reviewed to assess the safety and efficacy of the treatment. This will allow us to know whether or not the data suggests a phase 3 clinical trial is worthwhile.

Finally, it seems contacting the families or individuals suffering themselves would not be of benefit to anybody. The person who is at fault is the one advertising a cancer cure which has no evidence base behind it. You can’t really blame someone for wanting to try anything and everything to save their dying child. You can blame the clinic that promises a cure, takes £200,000 and delivers nothing though, as is likely to happen, as has happened so many times before at this clinic already. You can hardly blame Radiohead, Badly Drawn Boy and Peter Kay for wanting to help either, however it is important that the controversy of this clinic is brought into public awareness.

Update: 4/12/11

FDA

To contact the FDA to encourage them to complete the investigation they warned Burzynski they would perform in 2009 you can write to this address:

Gov. Rick Perry appointed many members of the TMB including its heads as well as members of the House Committee on Public Health and the Senate Committee on Health and Human Services, which oversee the TMB, apparently.

Uncritical newspaper reports can be considered as advertising by the MHRA, it may also be the Burzynski’s book and film also breach the MHRA guidance on advertising. It may also be that the clinic website itself does too and campaigns promoting the funds which promote the Burzynski clinic and research institute such as the Billie Butterfly Fund and Hope For Laura may also be in breach of this.

It may be, as the FDA and TMB have state, as well as proposed by the Merritts website, that Burzynski is 1) using ‘clinical trials’ as a facade to prescribe his non approved drugs and 2) also prescribing off label conventional drugs without consent at extortionate prices without declaring he owns the pharmacy which sells the drugs. These actions are very likely to be in breach of MHRA regulations too.

The charity commission regulate charities, in this case I suspect charities promoting the Burzynsk clinic beach a number of their guidance principles. Especially in causing serious harm to beneficiaries, in particular, vulnerable beneficiaries, criminality involving a charity, sham charities et up for illegal or improper purpose, charities deliberately being used for significant private advantage and where a charity’s independence is seriously called into question.

In a press release by the Burzynski Clinic, despite worldwide criticism, Burzynski stated that UK bloggers would be under legal investigation, it seems pretty obvious that UK critics were singled out due to the outdated libel laws in this country. Support the libel law reform campaign, which aims to promote better laws for protecting businesses and characters from biased, negative and defamatory reporting, whilst protecting individuals, scientists and researchers from big businesses and companies who dislike and attempt to silence negative reviews, criticism and having their product being pointed out as faulty or lacking an evidence base. Our current libel laws do not do this, they do not make sense in a world in which the internet exists, they do not offer any protection for individuals, scientists or researchers when making fair and evidence based judgements against a product, person, company or practice. The current libel laws in the UK cripple the concept of freedom of speech.

It is also recommended that you contact your MP due to the complex and political nature of this subject, including libel reform and breaches of law, advertising standards, reporting guidelines, health product regulation and consumer protection.